Drug Approval Package: ABSORICA LD

Company: Sun Pharmaceutical Industries Limited
Application Number: 211913
Approval Date: 11/05/2019

Drugs@FDA information available about ABSORICA LD

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FDA Approval Letter and Labeling

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)

FDA Application Review Files

• Product Quality Review(s) (PDF)
• Multi-Discipline Review (PDF)
• Proprietary Name Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)

Date created: March 16, 2020

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